Thursday, November 21, 2024 11/21/2024

2/2: A Randomized Controlled Trial of Pravastatin for the Prevention of Preeclampsia in High Risk Women

Award Number: U24HL140168
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT Preeclampsia complicates approximately 3% to 5% of pregnancies and remains a major cause of maternal and neonatal morbidity and mortality. Women who have experienced preeclampsia in one pregnancy are at high risk for preeclampsia in subsequent pregnancies with the magnitude of the risk depending on the severity and gestational age at delivery in the index pregnancy. Preeclampsia shares pathogenic similarities with adult cardiovascular diseases as well as many risk factors. Endothelial dysfunction and inflammation are fundamental for the initiation and progression of both. Prevention of preeclampsia using various supplements and medications have had limited success. In contrast, there is strong evidence that 3-hydroxy-3- methylglutaryl-coenzyme A reductase inhibitors (statins) are beneficial in primary and secondary prevention of cardiovascular mortality and other cardiovascular events. Biological plausibility, animal data, and pilot clinical trials support a similar role for pravastatin, a hydrophilic statin with a favorable safety profile, in preventing preeclampsia prevention. In addition, the current evidence from animal studies and human pregnancy exposure cohorts do not support previous teratogenicity claims of pravastatin. Therefore we propose a multicenter, double blind, placebo-controlled randomized clinical trial to determine whether prophylactic treatment with pravastatin administered early in pregnancy reduces preeclampsia in high-risk women. A total of 1,760 pregnant women at high risk for preeclampsia (due to history of preeclampsia in a prior pregnancy that required delivery before 36 0/7 weeks) will be randomized between 100/7 and 166/7 weeks to pravastatin 10 mg or similarly appearing placebo, daily at bedtime until delivery. Women and their neonates will be followed throughout pregnancy and up to six weeks postpartum to address the primary aim: evaluate whether treatment with pravastatin reduces the recurrence rate of preeclampsia; as well as the following secondary aims: (1) evaluate whether pravastatin improves maternal and neonatal outcomes; (2) assess the maternal and fetal/neonatal safety profile of pravastatin during pregnancy; and (3) determine whether pravastatin administration in pregnancy reverses the angiogenic imbalance associated with preeclampsia by reducing the concentrations of the anti-angiogenic factors soluble Fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sEng), and increasing that of placental growth factor PlGF (angiogenic).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$304,355 )
2025	2023	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	000	6	10/1/2024	NON-COMPETING CONTINUATION	-$304,355
														Subtotal = -$304,355

Issue Date FY: 2023 ( Subtotal = $1 )
2023	2023	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	002	6	9/9/2023	NON-COMPETING CONTINUATION	$1
2023	2022	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	001	5	4/22/2023	NON-COMPETING CONTINUATION	$0
2023	2021	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	000	4	4/22/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1

Issue Date FY: 2022 ( Subtotal = $1 )
2022	2022	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	001	5	9/16/2022	NON-COMPETING CONTINUATION	$1
2022	2021	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	000	4	9/13/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1

Issue Date FY: 2021 ( Subtotal = $1,969,560 )
2021	2021	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	000	4	7/22/2021	NON-COMPETING CONTINUATION	$1,969,560
														Subtotal = $1,969,560

Issue Date FY: 2020 ( Subtotal = $2,175,434 )
2020	2020	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	001	3	8/21/2020	NON-COMPETING CONTINUATION	$0
2020	2020	THE GEORGE WASHINGTON UNIVERSITY	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	000	3	8/19/2020	NON-COMPETING CONTINUATION	$2,175,434
														Subtotal = $2,175,434

Issue Date FY: 2019 ( Subtotal = $2,166,106 )
2019	2019	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	000	2	9/20/2019	NON-COMPETING CONTINUATION	$2,166,106
														Subtotal = $2,166,106

Issue Date FY: 2018 ( Subtotal = $1,091,697 )
2018	2018	THE GEORGE WASHINGTON UNIVERSITY	2121 I ST NW STE 601	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Cardiovascular Diseases Research	000	1	8/22/2018	NEW	$1,091,697
														Subtotal = $1,091,697

Grand Total All Awards = $7,098,444

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2/2: A Randomized Controlled Trial of Pravastatin for the Prevention of Preeclampsia in High Risk Women

Award Number: U24HL140168

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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